TMC435350-TiDP16-C105: Phase I, 3-way Crossover, Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.
17 de abril de 2013 actualizado por: Tibotec Pharmaceuticals, Ireland
Phase I, Open-label, 3-way Crossover Trial in Healthy Volunteers to Determine the Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.
The purpose of this study is to assess the interactions seen when somebody doses with TMC435350 and Rifampin (commercial form of antibiotic).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a Phase I, open-label, randomized, 3-way crossover trial in 18 healthy volunteers to investigate the potential drug-drug interaction between rifampin and TMC435350.
TMC435350 is a protease inhibitor in development for treatment of chronic HCV infection.
The goal is to assess the PK and safety data generated during 3 in-patients sessions.
At each session the volunteer will receive one of 3 treatments.
Rifampin is a medication commonly given to patients with Mycobacterium infections such as tuberculosis.
Some patients have both chronic HCV and tuberculosis, therefore it is necessary to know how the medications will affect each other when they are taken together.
Treatment A: TMC435350 200 mg q.d. for 7 days.
Treatment B: rifampin 600 mg q.d. for 7 days.
Treatment C: the combination of TMC435350 200 mg q.d.
+ rifampin 600 mg q.d. for 7 days.
There will be a washout period of at least 10 days between subsequent sessions.
Day 8 of a treatment session is the first day of the washout period.
Full pharmacokinetic profiles of TMC435350 will be determined on Day 7 of Treatments A and C. Full pharmacokinetic profiles of rifampin and its active metabolite 25-deacetyl rifampin will be determined on Day 7 of Treatments B and C. Safety and tolerability will be monitored continuously throughout the trial.
Volunteers will receive the dose regimens in Treatments A, B, C: Treatment A: TMC435350 200 mg q.d. for 7 days.
Treatment B: rifampin 600 mg q.d. for 7 days, Treatment C: the combination of TMC435350 200 mg+rifampin 600 mg both q.d. for 7 days.
The volunteers will enter the testing facility the night before the first dosing in each session (on Day -1 = one day before the first dosing) and stay in the testing facility until 72 hours after the last intake of medication on Day (10).
Tipo de estudio
Intervencionista
Inscripción (Actual)
21
Fase
- Fase 1
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Volunteers must meet all of the following inclusion criteria: Non smoking for at least 3 months prior to selection, Normal weight as defined by a body mass index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included), Informed Consent Form (ICF) signed voluntarily before the first trial related activity, Able to comply with protocol requirements, Normal 12-lead electrocardiogram (ECG) (in triplicate) at screening including: Normal sinus rhythm (heart rate [HR] between 40 and 100 bpm), QTc interval = 450 ms, QRS interval < 120 ms, PR interval = 220 ms
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs, and the results of blood biochemistry, and hematology tests and a urinalysis carried out at screening.
Exclusion Criteria:
- Past history of heart arrhythmias (extrasystole, tachycardia at rest) or having baseline prolongation of QTc interval > 450 ms
- history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT syndrome)
- Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post tubal ligation (without reversal operation)
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures
- Hepatitis A, B, or C infection (confirmed by hepatitis A antibody, hepatitis B surface antigen, or hepatitis C virus antibody, respectively) or human immunodeficiency virus - type 1 (HIV-1) or HIV-2 infection at screening
- A positive urine drug test at screening
- Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
- Currently significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability
- Any history of significant skin disease.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Secuencia de tratamiento CBA
|
200 mg taken by mouth once daily for 7 days
600 mg taken by mouth once daily for 7 days
The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.
|
|
Experimental: Treatment Sequence ABC
Participants will be randomized to each of the 6 different treatment sequences.
Each treatment sequence will consist of Treatment A (TMC435350 200 mg once daily for 7 days), Treatment B (rifampin 600 mg once daily for 7 days), and Treatment C (TMC435350 200 mg once daily+rifampin 600 mg once daily for 7 days).
Participants will receive 1 treatment (A, B, or C) during each treatment session.
There will be 3 treatment sessions, each treatment session will be separated by 10 days.
|
200 mg taken by mouth once daily for 7 days
600 mg taken by mouth once daily for 7 days
The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.
|
|
Experimental: Treatment Sequence BCA
|
200 mg taken by mouth once daily for 7 days
600 mg taken by mouth once daily for 7 days
The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.
|
|
Experimental: Treatment Sequence CAB
|
200 mg taken by mouth once daily for 7 days
600 mg taken by mouth once daily for 7 days
The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.
|
|
Experimental: Treatment Sequence BAC
|
200 mg taken by mouth once daily for 7 days
600 mg taken by mouth once daily for 7 days
The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.
|
|
Experimental: Treatment Sequence ACB
|
200 mg taken by mouth once daily for 7 days
600 mg taken by mouth once daily for 7 days
The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pharmacokinetic (PK) profile of TMC435350
Periodo de tiempo: On Day 1, 2, 4, 6, and 7 of Treatments A and C
|
The following PK parameters will be assessed: C0h on Day 7 of Treatments A and C; and C0h, Cmin, Cmax, tmax, AUC24h, Css,av, FI, λz, t1/2term, Ratio Cmin test/ref, Ratio C0h test/ref, Ratio Cmax test/ref, and Ratio AUC24h test/ref.
|
On Day 1, 2, 4, 6, and 7 of Treatments A and C
|
|
Pharmacokinetic (PK) profile of rifampin and 25-deacetylrifampin
Periodo de tiempo: On Day 1, 2, 4, 6, and 7 of Treatments B and C
|
The PK parameter of C0h will be assessed on Day 1, 2, 4 and 6 of Treatments B and C, and the PK parameters of C0h, Cmin, Cmax, tmax, AUC24h, Css,av, FI, λz, t1/2term, Ratio Cmin test/ref, Ratio C0h test/ref , Ratio Cmax test/ref , Ratio AUC24h test/ref on Day 7 of Treatments B and C.
|
On Day 1, 2, 4, 6, and 7 of Treatments B and C
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The number of participants reporting adverse events as a measure of safety and tolerability.
Periodo de tiempo: Up to 30 to 35 days after the last intake of study drug.
|
Up to 30 to 35 days after the last intake of study drug.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2008
Finalización primaria (Actual)
1 de diciembre de 2008
Finalización del estudio (Actual)
1 de diciembre de 2008
Fechas de registro del estudio
Enviado por primera vez
22 de agosto de 2008
Primero enviado que cumplió con los criterios de control de calidad
22 de agosto de 2008
Publicado por primera vez (Estimar)
26 de agosto de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de abril de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
17 de abril de 2013
Última verificación
1 de abril de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades del HIGADO
- Infecciones por Flaviviridae
- Hepatitis, Viral, Humana
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias grampositivas
- Infecciones por Actinomycetales
- Infecciones por micobacterias
- Hepatitis
- Hepatitis C
- Tuberculosis
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Inhibidores de la proteasa
- Agentes antibacterianos
- Agentes leprostáticos
- Inductores de enzimas de citocromo P-450
- Inductores de citocromo P-450 CYP3A
- Agentes antituberculosos
- Antibióticos, Antituberculosos
- Inductores de citocromo P-450 CYP2B6
- Inductores de citocromo P-450 CYP2C8
- Inductores del citocromo P-450 CYP2C19
- Inductores de citocromo P-450 CYP2C9
- Rifampicina
- Simeprevir
Otros números de identificación del estudio
- CR015412
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Hepatitis C
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AbbVieTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 1a
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AbbVie (prior sponsor, Abbott)TerminadoHepatitis C Crónica | Hepatitis C Genotipo 1 | Hepatitis C (VHC)Estados Unidos, Australia, Canadá, Francia, Alemania, Nueva Zelanda, Puerto Rico, España, Reino Unido
-
Trek Therapeutics, PBCTerminadoHepatitis C Crónica | Hepatitis C Genotipo 1 | Hepatitis C (VHC) | Infección viral de la hepatitis CEstados Unidos, Nueva Zelanda
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Trek Therapeutics, PBCTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 4 | Infección viral de la hepatitis CEstados Unidos
-
AbbVieTerminadoHepatitis C Crónica | Hepatitis C (VHC) | Hepatitis C Genotipo 1a
-
AbbVieTerminadoVirus de la hepatitis C | Virus de la hepatitis C crónica
-
AbbVie (prior sponsor, Abbott)TerminadoHepatitis C | Infección crónica por hepatitis C | VHC | Hepatitis C Genotipo 1Estados Unidos
-
Humanity and Health Research CentreBeijing 302 HospitalTerminadoInfección crónica por hepatitis CPorcelana
-
University Health Network, TorontoTerminadoInfección crónica por hepatitis CCanadá
-
AbbVie (prior sponsor, Abbott)TerminadoHepatitis C | Infección crónica por hepatitis C | VHC | Hepatitis C Genotipo 1Estados Unidos, Puerto Rico
Ensayos clínicos sobre TMC435350
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Tibotec Pharmaceuticals, IrelandTerminado
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Tibotec Pharmaceuticals, IrelandTerminado
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Tibotec Pharmaceuticals, IrelandTerminado